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Data / Medical devices / Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase (CCK): 159 FDA-registered makers in 26 countries

159 establishments in 26 countries are registered with the FDA to make Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase (product code CCK, Class 2, 21 CFR 868.1400). 70 of them have a 510(k) clearance or PMA approval on file and 9 have a recall event. The FDA has issued 307 510(k) clearances under this code, the latest on August 12, 2026, and lists 36 recall events (4 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code
CCK
Device class
2
Regulation
868.1400
Medical specialty
Anesthesiology

Makers by country

CountryMakers
United States59
China27
Mexico15
Germany8
Japan7
United Kingdom6
Malaysia5
Sweden4
Israel3
Finland3
India3
Canada2
Costa Rica2
Taiwan2
Singapore2
Brazil1
Turkey1
Romania1
Sri Lanka1
Poland1
South Korea1
Ireland1
France1
Thailand1
Estonia1
Lithuania1

Makers of Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Oridion Medical 1987 Ltd.Jerusalem, IsraelManufacturer, Specification developer18July 29, 2022070api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesComplaint file establishment, Specification developer15November 12, 2024060api.fda.gov
Nihon Kohden America, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler11June 10, 2025020api.fda.gov
Nihon Kohden Corp.SHINJUKU-KU Tokyo, JapanSpecification developer11June 10, 2025000api.fda.gov
Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology CenterTokorozawa Saitama, JapanComplaint file establishment, Specification developer10June 10, 2025000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer8August 19, 2003000api.fda.gov
Nihon Kohden Tomioka Production CenterTOMIOKA-SHI Gunma, JapanManufacturer6October 11, 2017000api.fda.gov
Productos Urologos De Mexico S.A. De C.V.MEXICALI Baja California, MexicoContract manufacturer, Manufacturer6June 20, 2018000api.fda.gov
Mercury Medical Enterprises, LLCClearwater, FL, United StatesManufacturer5March 17, 2017000api.fda.gov
Nihon Kohden Tomioka Corporation Nihon Kohden Kawamoto Production CenterFukaya-Shi Saitama, JapanManufacturer5June 10, 2025000api.fda.gov
Draegerwerk AG & Co. KGaALUEBECK Schleswig-Holstein, GermanyContract manufacturer, Manufacturer, Specification developer4April 5, 2023000api.fda.gov
Platinum Focus Group Ltd.London London, City of, United KingdomContract sterilizer, Exporter to the US, Manufacturer4May 1, 2019000api.fda.gov
Salter LabsEl Paso, TX, United StatesSpecification developer4December 14, 2016000api.fda.gov
Salter Labs de Mexico de S.A. de C.V.Chihuahua Mexico, MexicoContract manufacturer, Manufacturer4December 14, 2016000api.fda.gov
Flexicare Medical Ltd.RHONDDA CYNON TAFF Wales, United KingdomSpecification developer3April 30, 2014000api.fda.gov
Nihon Kohden America Fulfillment CenterFoothill Ranch, CA, United StatesManufacturer, Repackager or relabeler3June 10, 2025000api.fda.gov
Southmedic, Inc.BARRIE Ontario, CanadaManufacturer3November 21, 2023020api.fda.gov
Spacelabs Healthcare Inc.Snoqualmie, WA, United StatesManufacturer3March 21, 2013010api.fda.gov
WESTMED de Mexico, S.A de C.V.Tecate Baja California, MexicoManufacturer3December 14, 2016000api.fda.gov
Westmed, Inc.Tucson, AZ, United StatesContract manufacturer, Manufacturer, Specification developer3December 14, 2016000api.fda.gov
Westmed Javid de Mexico, S.A. de C.V.NOGALES Sonora, MexicoContract manufacturer, Manufacturer3December 14, 2016000api.fda.gov
Beijing Kingst Medical Device Co., Ltd.Beijing, ChinaContract manufacturer, Manufacturer2May 22, 2020000api.fda.gov
CovidienTIJUANA, B.C. Mexico, MexicoManufacturer2September 17, 2021000api.fda.gov
CovidienCiudad Juarez Chihuahua, MexicoManufacturer2March 22, 2019000api.fda.gov
CovidienLafayette, CO, United StatesSpecification developer2September 17, 2021031api.fda.gov
Draeger Medical Systems, Inc.Andover, MA, United StatesComplaint file establishment, Manufacturer2March 7, 2001000api.fda.gov
Ge Healthcare Finland OYHELSINKI Uusimaa, FinlandManufacturer, Specification developer2October 21, 2021000api.fda.gov
Industrial Vallera de Mexicali, S. A. de C. V.Mexicali Mexico, MexicoManufacturer2March 29, 2021000api.fda.gov
Masimo CorporationIrvine, CA, United StatesComplaint file establishment, Specification developer2March 29, 2021000api.fda.gov
Philips Medical Systems LtdaVarginha Minas Gerais, BrazilSpecification developer2January 12, 2006000api.fda.gov
Philips North America LLCExport, PA, United StatesContract manufacturer, Repackager or relabeler2December 14, 2016000api.fda.gov
Respironics Novametrix, LLCAndover, MA, United StatesSpecification developer2January 12, 2006010api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer2February 12, 2015000api.fda.gov
Volcano Corporation by Volcarica S.R.L.Coyol Alajuela, Costa RicaManufacturer2January 12, 2006000api.fda.gov
Aei Technologies Inc.Bastrop, TX, United StatesManufacturer1February 16, 1995000api.fda.gov
Affirm Medical Technologies Ii, LLCPiedmont, CA, United StatesComplaint file establishment, Specification developer1July 14, 2026000api.fda.gov
Applied Medical Technology, Inc.Brecksville, OH, United StatesManufacturer1November 24, 2014000api.fda.gov
AirLife Finland OyHelsinki Uusimaa, FinlandComplaint file establishment, Specification developer1April 30, 2018000api.fda.gov
Barbaras Development, Inc.Thousand Oaks, CA, United StatesManufacturer for export, Specification developer1June 4, 2025000api.fda.gov
Bluepoint Medical GMBH & Co. KGSelmsdorf Mecklenburg-Western Pomerania, GermanyContract manufacturer, Manufacturer1December 18, 2019000api.fda.gov
Besmed Health Business CorporationNew Taipei City, TaiwanExporter to the US, Manufacturer1February 5, 2015000api.fda.gov
CMI Health, Inc.Alpharetta, GA, United StatesSpecification developer1July 18, 2018000api.fda.gov
Customed, Inc.Fajardo, PR, United StatesManufacturer1October 3, 1989000api.fda.gov
CareFusion 303, INCSan Diego, CA, United StatesComplaint file establishment, Manufacturer, Specification developer1February 9, 2004000api.fda.gov
CareFusion 303, INC.San Diego, CA, United StatesComplaint file establishment, Manufacturer, Specification developer1February 9, 2004020api.fda.gov
ConvaTec Limited, GDC BuildingDeeside Flintshire, United KingdomSpecification developer1February 11, 1992000api.fda.gov
Dispo-Med (malaysia) Sdn BhdShah Alam Selangor, MalaysiaManufacturer1February 13, 2015000api.fda.gov
ICU Medical Healthcare Manufacturing S.A. de C.V.Tijuana, B.C. C.P. Baja California, MexicoManufacturer1April 17, 1991000api.fda.gov
Intersurgical Ltd.Wokingham, Berkshire, United KingdomSpecification developer1December 20, 2012000api.fda.gov
Inventeur, LLCSaint Petersburg, FL, United StatesSpecification developer1December 16, 2024000api.fda.gov
Jaeger Medical GmbHHOECHBERG Bavaria, GermanyComplaint file establishment, Manufacturer1October 12, 1984000api.fda.gov
Medipines CorporationYorba Linda, CA, United StatesManufacturer, Specification developer1January 11, 2019000api.fda.gov
Mediplus Ltd.HIGH WYCOMBE, BUCKS Buckinghamshire, United KingdomComplaint file establishment, Exporter to the US, Specification developer1November 25, 2013000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer1January 22, 1993000api.fda.gov
Meditera Tibbi Malzeme Sanayi ve Ticaret A.S.Tire Izmir, TurkeyManufacturer1January 17, 2020000api.fda.gov
Nasorcap Medical, Inc.Venetia, PA, United StatesManufacturer1August 14, 1992000api.fda.gov
Ningbo Besmed Medical Equipment Corp.NINGBO Zhejiang, ChinaManufacturer1February 5, 2015000api.fda.gov
Nonin Medical, Inc.Plymouth, MN, United StatesManufacturer1August 12, 1999000api.fda.gov
Nihon Kohden Tomioka CorporationGunma Tokyo, JapanManufacturer1July 25, 2002000api.fda.gov
Orantech Inc.Shenzhen Guangdong, ChinaManufacturer1May 31, 2018000api.fda.gov
Pneuma Therapeutics, Inc.San Marcos, CA, United StatesSpecification developer1January 30, 2023000api.fda.gov
Philips Medizin Systeme Boeblingen GmbHBOEBLINGEN Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer, Specification developer1December 26, 2017000api.fda.gov
Respironics Inc.Murrysville, PA, United StatesComplaint file establishment, Manufacturer1December 13, 2005000api.fda.gov
Seebreath ABStockholm, SwedenSpecification developer1July 13, 2012000api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer1April 19, 2018000api.fda.gov
Tri-Anim Health Services, Inc.Dublin, OH, United StatesSpecification developer1November 16, 2022000api.fda.gov
Teleflex Medical de Tecate, S. de R.L de C.V.TECATE Baja California, MexicoManufacturer1September 10, 1996000api.fda.gov
Tylenol Medical Instruments Co., Ltd.Zhongshan Guangdong, ChinaContract manufacturer, Manufacturer1February 6, 2019000api.fda.gov
Unimed Medical Supplies IncShenzhen Guangdong, ChinaManufacturer1March 4, 2021000api.fda.gov
Vacumed, Div. Of Vacumetrics, Inc.Ventura, CA, United StatesManufacturer1May 26, 1998000api.fda.gov
Advanced Instrumentations, Inc.Miami, FL, United StatesManufacturer0000api.fda.gov
Athena GTXJohnston, IA, United StatesComplaint file establishment, Manufacturer, Remanufacturer0000api.fda.gov
Axcesor LLCMenomonee Falls, WI, United StatesContract manufacturer0000api.fda.gov
Amphenol Medical Technologies (Dongguan) Co., Ltd.Dongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
Beijing Aeonmed Co., Ltd.Sanhe Hebei, ChinaContract manufacturer0000api.fda.gov
Bound Tree Medical, LLCGrand Prairie, TX, United StatesManufacturer0000api.fda.gov
Breas Medical ABMOLNLYCKE Vastra Gotaland, SwedenManufacturer0000api.fda.gov
Breas Medical, Inc.N Billerica, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Cadex Electronics, Inc.RICHMOND British Columbia, CanadaContract manufacturer0000api.fda.gov
Caf Medical Solutions IncHockley, TX, United StatesManufacturer0000api.fda.gov
Celestica (romania) SRLBors Bihor, RomaniaContract manufacturer0000api.fda.gov
Contec Medical Systems Co., LtdQinhuangdao Hebei, ChinaManufacturer0000api.fda.gov
Digicare Biomedical Technology, Inc.Boynton Beach, FL, United StatesManufacturer0000api.fda.gov
Draeger Interservices GmbHLuebeck Schleswig-Holstein, GermanyContract manufacturer0000api.fda.gov
EDAN Diagnostics, Inc.San Diego, CA, United StatesContract manufacturer0000api.fda.gov
Edan Instruments, Inc.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Emi (dongguan) Asia LimitedDongguan City Guangdong, ChinaContract manufacturer0000api.fda.gov
Engineered Medical Systems, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Flexicare Medical (dongguan) Ltd.DONGGUAN CITY Guangdong, ChinaContract manufacturer0000api.fda.gov
Forefront (xiamen) Medical Devices Co., Ltd.Xiamen Fujian, ChinaContract manufacturer0000api.fda.gov
Forefront Medical Technology (jiangsu) Co.,ltdChangzhou Jiangsu, ChinaContract manufacturer0000api.fda.gov
Fukuda Denshi Co., Ltd.Shiroi-shi Chiba, JapanManufacturer0000api.fda.gov
Fukuda Denshi Co., Ltd.Bunkyo-ku Tokyo, JapanSpecification developer0000api.fda.gov
Flash GlobalLockbourne, OH, United StatesContract manufacturer0000api.fda.gov
Flexicare Lanka (Pvt) LtdBandaragama Western, Sri LankaContract manufacturer0000api.fda.gov
Flextronics Manufacturing (Singapore) Pte LtdSINGAPORE South East, SingaporeContract manufacturer0000api.fda.gov
Freespira, IncKirkland, WA, United StatesComplaint file establishment, Manufacturer, Remanufacturer, Specification developer0000api.fda.gov
Frohe Sweden ABTyreso, SwedenContract manufacturer0000api.fda.gov
Gamamed Vascular Systems Inc.Loveland, CO, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Ge Medical Systems (china) Co., Ltd.WUXI Jiangsu, ChinaManufacturer, Specification developer0000api.fda.gov
Ge Medical Systems Information TechnologiesEl Paso, TX, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V.JUAREZ Chihuahua, MexicoManufacturer0000api.fda.gov
GE Medical Systems Information Technologies, Inc.Waukesha, WI, United StatesSpecification developer0000api.fda.gov
GE Medical Systems Information Technologies, Inc.Wauwatosa, WI, United StatesSpecification developer0000api.fda.gov
GPE MedTech Systeme GmbHDassow Mecklenburg-Western Pomerania, GermanyContract manufacturer0000api.fda.gov
Guangdong Biolight Meditech Co., LtdZhuhai Guangdong, ChinaManufacturer0000api.fda.gov
Hosmed Inc.Doral, FL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Intersurgical Medical Apparatus (changzhou) Co., Ltd.Changzhou City Jiangsu, ChinaContract manufacturer0000api.fda.gov
Industrial Vallera de Mexicali, S.A. de C.V. (Terra)Mexicali Baja California, MexicoManufacturer0000api.fda.gov
Intersurgical Medical Sdn. Bhd.Simpang Ampat Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Jiangyin Sinbon Electronics Co LtdJiangyin Jiangsu, ChinaContract manufacturer0000api.fda.gov
KB Components Finland OyNurmijarvi Etela-Karjala, FinlandContract manufacturer0000api.fda.gov
Kimball Electronics Poland Sp.z o.oTarnowo Podgorne Wielkopolskie, PolandContract manufacturer0000api.fda.gov
Mediana Co., Ltd.Wonju-Si, Gangwon-do, South KoreaManufacturer0000api.fda.gov
Medisize Ireland Ltd.LETTERKENNY Donegal, IrelandContract manufacturer0000api.fda.gov
MINDRAY DS USA, Inc.Mahwah, NJ, United StatesComplaint file establishment, Contract manufacturer0000api.fda.gov
Masimo Medical Technologies (Malaysia) SDN BHDPasir Gudang Johor, MalaysiaComplaint file establishment, Manufacturer0000api.fda.gov
MedDev Manufacturing Sdn BhdKlang Selangor, MalaysiaContract manufacturer0000api.fda.gov
Ningbo Shengyurui Medical Appliance Co.Ningbo Zhejiang, ChinaContract manufacturer0000api.fda.gov
Ningbo Xinwell Medical Technology Co., Ltd.Cixi Zhejiang, ChinaContract manufacturer0000api.fda.gov
NextPhase Medical Devices Mexico LLCTIJUANA Baja California, MexicoContract manufacturer0000api.fda.gov
Osi Optoelectronics (medical Division)Hawthorne, CA, United StatesContract manufacturer0000api.fda.gov
Osi Systems Pvt Ltd(optoelectronics Division)HYDERABAD Telangana, IndiaContract manufacturer0000api.fda.gov
Oricare Inc.Quakertown, PA, United StatesSpecification developer0000api.fda.gov
Physio-Control, Inc.Redmond, WA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Plaxtron Industrial (M) Sdn. Bhd.IPOH Perak, MalaysiaContract manufacturer0000api.fda.gov
POM Medical, LLCMoorpark, CA, United StatesContract manufacturer0000api.fda.gov
PROTOTAL Sweden ABJonkoping, SwedenManufacturer0000api.fda.gov
Pulsion Medical Systems SeAschheim, GermanyContract manufacturer0000api.fda.gov
Philips FranceParis, FranceSpecification developer0000api.fda.gov
Philips Goldway (Shenzhen) Industrial Inc.SHENZHEN Guangdong, ChinaSpecification developer0000api.fda.gov
Philips North America LLCCambridge, MA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Philips North America LLCAndover, MA, United StatesSpecification developer0020api.fda.gov
Philips North America LLCMurrysville, PA, United StatesContract manufacturer0000api.fda.gov
Polimeros Formula de Tecate S.A de C.VTecate Baja California, MexicoContract manufacturer0000api.fda.gov
Quasar Medical (Thailand) Co., LtdChonburi Chon Buri, ThailandContract manufacturer0000api.fda.gov
RAUMEDIC Estonia ASTallinn Harjumaa, EstoniaContract manufacturer0000api.fda.gov
Remote Diagnostic Technologies Ltd.FARNBOROUGH Hampshire, United KingdomComplaint file establishment, Manufacturer0000api.fda.gov
Repair Operations CenterOak Creek, WI, United StatesRemanufacturer0000api.fda.gov
Sanmina- Sci Israel Medical Systems Ltd.Maalot-Tarshiha Northern, IsraelContract manufacturer0000api.fda.gov
Shenzhen Comen Medical Instruments Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Creative Industry Co., LtdSHENZHEN Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.Shenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Skanray Technologies LimitedMysore Karnataka, IndiaComplaint file establishment, Contract manufacturer, Manufacturer0000api.fda.gov
SMC Costa Rica Division S.R.L.El Coyol Alajuela, Costa RicaContract manufacturer0000api.fda.gov
Suzhou Jingle Polymer Medical Apparatus Co., Ltd.SUZHOU Jiangsu, ChinaContract manufacturer0000api.fda.gov
Salaera, LLC d.b.a MaxtecSalt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
Sanmina-SCI Systems Singapore Pte. Ltd.SINGAPORE North East, SingaporeContract manufacturer0000api.fda.gov
Shenzhen Mindray Bio-Medical Electronics Co.,LTDSHENZHEN Guangdong, ChinaExporter to the US, Specification developer0000api.fda.gov
Siemens Healthineers AGFORCHHEIM Bavaria, GermanyManufacturer0000api.fda.gov
Sistemas Medicos Alaris S.A de C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Technical Services for Electronics, Inc.New Taipei City, TaiwanContract manufacturer0000api.fda.gov
UAB IntersurgicalPABRADE Svencionys, LithuaniaContract manufacturer0000api.fda.gov
Usr Electronic Systems (1987) LtdKarmiel Northern, IsraelContract manufacturer0000api.fda.gov
Vincent Medical (dong Guan) Manufacturing Co., Ltd.Dong Guan City Guangdong, ChinaContract manufacturer0000api.fda.gov
Wipro Ge Medical Device Manufacturing Private LimitedBangalore Karnataka, IndiaManufacturer0000api.fda.gov
Westmed de Mexico, S.A de C.VNOGALES Sonora, MexicoContract manufacturer0000api.fda.gov
Zhongshan Hongze Medical Technology Co., Ltd.Zhongshan Guangdong, ChinaContract manufacturer0000api.fda.gov
Zoll Medical CorporationChelmsford, MA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov

Updated August 12, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.